Elexir
The FDA filing names ELEXIR model ALLIVE2 as a transcutaneous electrical nerve stimulator applied to the forehead. A self-adhesive electrode is positioned over the upper branches of the…
The FDA filing names ELEXIR model ALLIVE2 as a transcutaneous electrical nerve stimulator applied to the forehead.
A self-adhesive electrode is positioned over the upper branches of the trigeminal nerve on both sides, as described in the filing.
Use Described in Filing
The filing states that ELEXIR is indicated for acute treatment of migraine and prophylactic treatment of episodic migraine in patients 18 years of age or older.
Who Else Makes It
Concentrated in Guangdong (2), Zhejiang (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| JDI Electronics Factory | Dongguan | Guangdong | Contract manufacturer | 7 |
| Shenzhen Dongdixin Technology Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 18 |
| WAT Medical Technology Inc. | Ningbo | Zhejiang | Repacker / relabeller | 4 |
Record
| Listed by | NU Eyne Co., Ltd., South Korea |
|---|---|
| FDA product code | PCC |
| Device type | Stimulator, Nerve, Electrical, Transcutaneous, For Migraine |
| Device class | Class 2 |
| Regulation | 21 CFR 882.5891 |
| Establishment | Manufacturer |
| 510(k) | K211380 |
| Record published | 2023-08-04 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
| Storage | Storage environment atmospheric pressure 50 to 106 KiloPascal; Storage environment humidity 5 to 85 % RH; Storage environment temperature -10 to 45 °C; Handling environment atmospheric pressure 70 to 106 KiloPascal; Handling environment humidity 5 to 85 % RH; Handling environment temperature 10 to 40 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| ALLIVE2 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Cefaly® | Cefaly Technology Sprl | 14 |
| HeadaTerm | WAT Medical Technology Inc. | 3 |
| Relivion | Neurolief Inc. | 2 |
| Allive | NU Eyne Co., Ltd. | 1 |
| Relivion MG App | Neurolief Inc. | 1 |
| Tens 7000 | Drive DeVilbiss Healthcare | 1 |
| Doopang | Ybrain Inc. | 1 |
| Relivion MG PMI Physician Interface | Neurolief Inc. | 1 |
| Enso | Hinge Health Inc. | 1 |
| AccuRelief | Drive DeVilbiss Healthcare | 1 |
| Elexir 2.0 | NU Eyne Co., Ltd. | 1 |
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K242719 | 2024-11-06 |
| K211380 | 2021-07-30 |
| K192773 | 2019-12-06 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.